free and clear useability - henry scheincommitted to science, committed to you. new isovue® imaging...
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![Page 1: FREE AND CLEAR USEABILITY - Henry ScheinCommitted to Science, Committed to You. New ISOVUE® Imaging Bulk Package,* the first and only FDA-approved contrast medium that changes the](https://reader033.vdocuments.mx/reader033/viewer/2022050520/5fa3babab409cd716e765ecd/html5/thumbnails/1.jpg)
Committed to Science, Committed to You.™
New ISOVUE® Imaging Bulk Package,* the first and only FDA-approved contrast medium that changes the rules on compliance in the CT suite1
FREE AND CLEAR USEABILITY
C 100M 72.94Y 0K 1.96
R 0G 85B 164
Pantone Re�ex Blue C
MR Suite I/Dx SuiteCT SuiteIntroducing a breakthrough in contrast media labeling
![Page 2: FREE AND CLEAR USEABILITY - Henry ScheinCommitted to Science, Committed to You. New ISOVUE® Imaging Bulk Package,* the first and only FDA-approved contrast medium that changes the](https://reader033.vdocuments.mx/reader033/viewer/2022050520/5fa3babab409cd716e765ecd/html5/thumbnails/2.jpg)
NEW ISOVUE® (iopamidol injection) Imaging Bulk Package*
FREE AND CLEAR USEABILITY
INDICATIONS AND USAGE: ISOVUE (Iopamidol Injection) Imaging Bulk Package (IBP) is indicated for intravenous contrast enhancement of computed tomographic (CECT) imaging of the head and body in adult and pediatric patients.
IMPORTANT SAFETY INFORMATION: Isovue IS NOT FOR INTRATHECAL USE. Iopamidol Injection is available as Isovue-M® for intrathecal administration.
Caution must be exercised in patients with severely impaired renal function, those with combined renal and hepatic disease, or anuria, particularly when larger and repeat doses are administered. Radiopaque diagnostic contrast agents are potentially hazardous in patients with multiple myeloma or other paraproteinemia, particularly in those with therapeutically resistant anuria. Caution should be exercised in hydrating patients with underlying conditions that may be worsened by fluid overload, such as congestive heart failure. Diabetic nephropathy may predispose to acute renal impairment following intravascular contrast media administration. Acute renal impairment following contrast media administration may precipitate lactic acidosis in patients who are taking biguanides. Preparatory dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, diabetic patients, and in susceptible nondiabetic patients (often elderly with preexisting renal disease). Patients should be well hydrated prior to and following iopamidol administration.
The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions, should always be considered. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies).
The Isovue Imaging Bulk Package is for use with an automated contrast injector or a contrast management system approved or cleared for use with it.
Please see full Prescribing Information enclosed in pocket of this brochure.You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Enhance safety• Encourages individualized dosing, particularly suitable for high-risk patients
• Sterility is maintained with proper use of aseptic technique—a single puncture to the IBP container, and a recap-able luer lock on the distal end of the transfer set
• ISOVUE provides established efficacy and safety, with 4,500+ clinical studies and 25+ years of trusted use2
Increase efficiency and throughput • Accommodates multiple patients and procedures1
• Streamlines processes by reducing time required for equipment setup
Dose on demand without fear of multidosing citations• FDA-approved for use at point of care—the CT Suite
• ISOVUE Imaging Bulk Package* provides convenient, 10-hour dosing from the same container1†
• The only multidose product approved for use in the CT suite without the need for a suitable work area, such as a laminar flow hood1
Reduce waste, reduce cost • Eliminates the overflow of waste from single-use containers, with no need to waste
excess contrast media
• Fewer containers leads to decreased disposal costs
†A maximum use time of 10 hours from the initial closure entry is permitted to complete fluid transfer.
![Page 3: FREE AND CLEAR USEABILITY - Henry ScheinCommitted to Science, Committed to You. New ISOVUE® Imaging Bulk Package,* the first and only FDA-approved contrast medium that changes the](https://reader033.vdocuments.mx/reader033/viewer/2022050520/5fa3babab409cd716e765ecd/html5/thumbnails/3.jpg)
INDICATIONS FOR USE: The Bracco Injeneering Transfer Set is a component of a contrast management system and is indicated for the transfer of Isovue (iopamidol injection) contrast media as supplied in an Imaging Bulk Package to empty sterile syringes on single-use only syringe-based contrast injector systems indicated for the controlled, automatic administration on the venous side, of contrast agents for CT procedures. The Transfer Set is to be discarded after the contrast media container has been depleted or 10 hours has elapsed since the container was penetrated, whichever occurs first.
C 100M 72.94Y 0K 1.96
R 0G 85B 164
Pantone Re�ex Blue C
Introducing
NEW ISOVUE® (iopamidol injection) Imaging Bulk Package*
FREE AND CLEAR USEABILITY
Now you can easily and safely transfer ISOVUE (iopamidol injection) Imaging Bulk Package* in the CT suite with the new, FDA-approved Bracco Injeneering Transfer Set
The first system exclusively designed to give you everything you need to optimize use
• Accommodates multiple patients and procedures1
• Streamlines processes by reducing time required for equipment setup
Introducing Bracco’s Complete Contrast Management System MULTIDOSING COMPLIANCEin the CT Suite
![Page 4: FREE AND CLEAR USEABILITY - Henry ScheinCommitted to Science, Committed to You. New ISOVUE® Imaging Bulk Package,* the first and only FDA-approved contrast medium that changes the](https://reader033.vdocuments.mx/reader033/viewer/2022050520/5fa3babab409cd716e765ecd/html5/thumbnails/4.jpg)
Committed to Science, Committed to You.™
New ISOVUE® Imaging Bulk Package,* the first and only FDA-approved contrast medium that changes the rules on compliance in the CT suite1
FREE AND CLEAR USEABILITY
INDICATIONS AND USAGE ISOVUE (Iopamidol Injection) Imaging Bulk Package (IBP) is indicated for intravenous contrast enhancement of computed tomographic (CECT) imaging of the head and body in adult and pediatric patients.
IMPORTANT SAFETY INFORMATION Isovue IS NOT FOR INTRATHECAL USE. Iopamidol Injection is available as Isovue-M® for intrathecal administration.
Caution must be exercised in patients with severely impaired renal function, those with combined renal and hepatic disease, or anuria, particularly when larger and repeat doses are administered. Radiopaque diagnostic contrast agents are potentially hazardous in patients with multiple myeloma or other paraproteinemia, particularly in those with therapeutically resistant anuria. Caution should be exercised in hydrating patients with underlying conditions that may be worsened by fluid overload, such as congestive heart failure. Diabetic nephropathy may predispose to acute renal impairment following intravascular contrast media administration. Acute renal impairment following contrast media administration may precipitate lactic acidosis in patients who are taking biguanides. Preparatory dehydration is dangerous and may contribute to acute renal failure in patients with advanced vascular disease, diabetic patients, and in susceptible nondiabetic patients (often elderly with preexisting renal disease). Patients should be well hydrated prior to and following iopamidol administration.
The possibility of a reaction, including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions, should always be considered. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies).
The Isovue Imaging Bulk Package is for use with an automated contrast injector or a contrast management system approved or cleared for use with it.
Please see full Prescribing Information enclosed in pocket of this brochure. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.References: 1. Isovue® (iopamidol injection) Imaging Bulk Package full Prescribing Information. Bracco Diagnostics Inc.; June 2014. 2. Isovue® launched in the United States in 1986.
Distributed by: Bracco Diagnostics Inc. 259 Prospect Plains Road, Building H Monroe Township, New Jersey 08831 USA
Phone: (800) 631-5245 Fax: (609) 514-2424
Email: [email protected] Website: imaging.bracco.com/us-en/isovue
Customer Service: 1-877-BRACCO 9 (1-877-272-2269)
Professional Services: 1-800-257-5181 (option 1)
© 2014 Bracco Diagnostics Inc. All Rights Reserved. 14-041514
Isovue is a registered trademark of Bracco Diagnostics Inc.
Isovue® and Isovue-M® are currently manufactured for Bracco Diagnostics Inc. at two locations: BIPSO GmbH, Singen (Germany) and Patheon Italia S.p.A., Ferentino (Italy).
Transfer Set manufactured by: Bracco Injeneering SA Avenue de Sévelin 46 CH - 1004 Lausanne, Switzerland
Introducing
C 100M 72.94Y 0K 1.96
R 0G 85B 164
Pantone Re�ex Blue C
CHANGING THE RULES...
ORDERING INFORMATION
ISOVUE®-300* (iopamidol injection 61%)Ten 200 mL bottles†
Six 500 mL bottles†
ISOVUE®-370* (iopamidol injection 76%)Ten 200 mL bottles†
Six 500 mL bottles†
Transfer Set
NDC No.0270-1315-450270-1315-95
0270-1316-450270-1316-95
*Concentration (mgI/mL). †Not for direct infusion.
SKU131545131595
131645131695
017349
With Bracco’s Complete Contrast Management System